Research | Web exclusive FLOW (finding lasting options for women) Multicentre randomized controlled trial comparing with menstrual cups

Courtney Howard MD CCFP(EM) Caren Lee Rose MSc Konia Trouton MD CCFP MPH Holly Stamm MD CCFP Danielle Marentette MD CCFP Nicole Kirkpatrick MD CCFP(EM) Sanja Karalic MD CCFP MSc Renee Fernandez MD CCFP Julie Paget MD CCFP Abstract Objective To determine whether menstrual cups are a viable alternative to tampons.

Design Randomized controlled trial. EDITOR’S KEY POINTS Setting Prince George, Victoria, and Vancouver, BC. • Patients are increasingly asking physicians about more environmentally friendly Participants A total of 110 women aged 19 to 40 years who had previously alternatives to disposable menstrual used tampons as their main method of menstrual management. management products, particularly menstrual cups, and about their Intervention Participants were randomized into 2 groups, a group effectiveness compared with tampons. and a group. Using online diaries, participants tracked 1 Although the safety and efficacy of using their regular method and 3 menstrual cycles using menstrual cups have been studied the method of their allocated group. previously, a randomized controlled trial comparing cups with tampons has never Main outcome measures Overall satisfaction; secondary outcomes been done. included discomfort, urovaginal , cost, and . • This study compared the experiences of Results Forty-seven women in each group completed the final survey, 5 of women using only tampons with women whom were subsequently excluded from analysis (3 from the tampon group using only menstrual cups over a period and 2 from the menstrual cup group). Overall satisfaction on a 7-point of 3 menstrual cycles; in terms of overall Likert scale was higher for the menstrual cup group than for the tampon satisfaction, study participants were as group (mean [standard deviation] score 5.4 [1.5] vs 5.0 [1.0], respectively; satisfied with menstrual cups as they were P = .04). Approximately 91% of women in the menstrual cup group said with tampons if not more satisfied, and they would continue to use the cup and recommend it to others. Women 91% said they would continue to use the used a median of 13 menstrual products per cycle, or 169 products per year, cup and recommend it to others. which corresponds to approximately 771 248 400 products used annually in Canada. Estimated cost for tampon use was $37.44 a year (similar to the • Although subjective vaginal discomfort retail cost of 1 menstrual cup). Subjective vaginal discomfort was initially was higher in menstrual cup users, this higher in the menstrual cup group, but the discomfort decreased with con- decreased with continued use and did tinued use. There was no significant difference in physician-diagnosed uro- not affect the prevalence of urovaginal vaginal symptoms between the 2 groups. symptoms. Women took advantage of the support offered in this study, suggesting Conclusion Both of the menstrual management methods evaluated were that there is a role for primary care well tolerated by subjects. Menstrual cups are a satisfactory alternative to providers in providing counseling to help tampons and have the potential to be a sustainable solution to menstrual optimize menstrual management. management, with moderate cost savings and much-reduced environmen- tal effects compared with tampons. • Menstrual cups are a comparable alternative to tampons; over the long Trial registration number C06-0478 (ClinicalTrials.gov). term, they are less costly and produce less environmental waste. This article has been peer reviewed. Cet article a fait l’objet d’une révision par des pairs. • The study was limited to a small group of Can Fam Physician 2011;57:e208-15 mostly white women over a relatively short period of time; further long-term study in This article is eligible for Mainpro-M1 credits. credits. To earn a more diverse population is required to Tocredits, earn credits,go to www.cfp.ca go to www.cfp.ca and click and on click the onMainpro the Mainpro link. link. confirm the generalizability of these results. e208 Canadian Family Physician • Le Médecin de famille canadien | Vol 57: JUNE • JUIN 2011 Exclusivement sur le web | Recherche Flux menstruel : à la recherche d’une alternative durable pour les femmes Essai clinique randomisé multicentrique comparant les tampons hygiéniques aux coupes menstruelles Courtney Howard MD CCFP(EM) Caren Lee Rose MSc Konia Trouton MD CCFP MPH Holly Stamm MD CCFP Danielle Marentette MD CCFP Nicole Kirkpatrick MD CCFP(EM) Sanja Karalic MD CCFP MSc Renee Fernandez MD CCFP Julie Paget MD CCFP

Résumé Points de repère du rédacteur Objectif Déterminer si les coupes menstruelles constituent une solution • Les médecins reçoivent de plus en plus de de remplacement satisfaisante aux tampons hygiéniques. questions sur une façon de se débarrasser des produits de qui soit plus Type d’étude Essai clinique randomisé. respectueuse de l’environnement, comme par exemple l’utilisation des coupes menstruelles Contexte Prince George, Victoria et Vancouver, BC. et leur efficacité par rapport aux tampons hygiéniques. Même si l’efficacité et Participantes Un total de 110 femmes de 19 à 40 ans qui avaient l’innocuité des coupes menstruelles ont antérieurement utilisé surtout des tampons pour leurs . déjà été étudiées, il n’y a jamais eu d’essai clinique randomisé comparant les coupes aux Intervention Les participantes ont été assignées au hasard à 2 groupes, tampons. un groupe tampons et un groupe coupes menstruelles. Elles ont utilisé un journal en ligne pour inscrire des commentaires sur un premier cycle • Cette étude a comparé l’expérience de menstruel avec leur méthode habituelle et 3 autres cycles avec la méthode femmes qui, sur une période de 3 cycles menstruels, ont utilisé uniquement des choisie pour leur groupe. tampons à d’autres qui n’ont utilisé que des coupes; en termes de satisfaction globale, Principaux paramètres à l’étude Satisfaction globale; les issues celles du groupe coupe menstruelle étaient secondaires incluaient l’inconfort, les vaginales, le coût et la aussi, sinon plus satisfaites que celles du disposition des déchets. groupe tampon hygiénique, et 91 % d’entre elles ont déclaré qu’elles continueraient à Résultats Quarante-sept femmes de chaque groupe ont complété le utiliser les coupes et à le recommander à questionnaire final, dont 5 ont été subséquemment exclus de l’analyse (3 d’autres. du groupe tampons et 2 du groupe coupes menstruelles). Mesurée sur une échelle de Likert de 7 points, la satisfaction globale était plus élevée dans • Quoique les utilisatrices des coupes le groupe coupes menstruelles que dans le groupe tampons (moyenne rapportaient davantage d’inconfort vaginal, [écart type] 5.4 [1.5] vs 5.0 [1.0] respectivement; P = .04). Environ 91 % des ce problème diminuait avec le temps et femmes du groupe coupes menstruelles ont dit qu’elles continueraient à n’avait pas d’influence sur la prévalence des utiliser les coupes et à les recommander à d’autres. Les participantes ont symptômes uro-vaginaux . Les femmes ont utilisé une médiane de 13 produits menstruels par cycle, ou 169 produits bénéficié du support offert dans cette étude, par année, ce qui correspond à environ 771 248 400 produits par année ce qui laisse croire que les intervenants de au Canada. Le coût estimé pour utiliser des tampons était de 37,44 $ par première ligne ont un rôle à jouer pour aider année (semblable au prix de détail d’une coupe menstruelle). Il y avait à optimiser la gestion des menstruations. plus d’inconfort vaginal subjectif dans le groupe coupes menstruelles, mais ce problème diminuait avec l’usage. Il n’y avait pas de différence • Les coupes menstruelles représentent une significative entre les 2 groupes quant au taux de symptômes uro- solution de rechange à long terme aussi vaginaux diagnostiqués par un médecin. valable que les tampons; elles sont moins coûteuses et génèrent moins de déchets Conclusion Les 2 méthodes de gestion des menstruations évaluées environnementaux. étaient bien tolérées par les participantes. Les coupes menstruelles constituent une solution de rechange satisfaisante aux tampons et elles • Cette étude portait sur un groupe limité de sont susceptibles de représenter un solution à long terme pour la gestion femmes caucasiennes et sur une période des menstruations, avec un coût un peu moindre et beaucoup moins relativement courte; il faudra d’autres études d’effets sur l’environnement par rapport aux tampons. à long terme sur une population plus diversifiée pour que ces résultats puissent Numéro d’enregistrement de l’étude C06-0478 (ClinicalTrials.gov). être généralisés.

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am using tampons right now, but I would like to from November 2006 to September 2007. They were try a menstrual cup. Do they work as well as tam- recruited via posters in family practice offices, e-mail I pons?” This patient query is becoming more com- lists, and stories in local media. Women between 19 and mon. Menstrual cups are flexible, reusable cups made 40 years of age with monthly menstrual flow who used of rubber or silicone that are worn intravaginally to col- tampons as their primary method of menstrual manage- lect menstrual flow.1 Interest in their use is increasing, ment were eligible. Exclusion criteria were sensitivity largely because of public desire for more environmen- or allergy to silicone, active vaginal or urogenital infec- tally friendly menstrual products.2 tion, pregnancy or plans to become pregnant before the Studies on tampons show that they are well toler- end of the study, use of systemic antimicrobials within ated.3,4 There is no conclusive evidence that tampons sub- the previous 14 days, inability to understand the nature stantially affect rates of or and purpose of the study, and inability to understand (UTI).5-10 Independent research in the 1980s found toxic and express themselves in written and spoken English. shock syndrome to be associated with high absorbency All interested participants who fulfilled the study criteria tampons and the aerobic production of Staphylococcus were sent an electronic copy of the consent form and aureus, which led to a change in tampon composition and were scheduled for an information session. instructions for use.11-15 The first studies on menstrual cups done in the 1960s Study design, intervention, and measurements showed that they were also well tolerated, with most Upon arrival at the information session, women were women becoming comfortable with use after a 1- to sequentially enrolled and randomized to the tampon 2-month adjustment period.16-19 A 1995 study done in group or the menstrual cup group using a computer- Toronto, Ont, asked participants to use the cup for 1 generated, site-specific block randomization scheme. year and found that 62% of those who used the cup for Participants filled out a prestudy survey and received 2 or more cycles found it acceptable.20 A recent British instruction regarding manufacturer-recommended use study asking 53 medical students to record 3 baseline of tampons and menstrual cups. cycles then 3 cycles with the Mooncup menstrual cup Participants randomized to the menstrual cup group found that 55% continued using the Mooncup at the were each given a DivaCup, a Canadian-made sili- end of the study.21 cone menstrual cup purchased with study funds, while In terms of infection, an independent study showed that women in the tampon group were reimbursed the a menstrual cup did not amplify the S aureus toxin when equivalent value of a menstrual cup upon study comple- tested in vitro,22 and an older study found less bacterial tion. The first menstrual cycle was treated as a run-in growth obtained from cultures of the used cup than from cycle, during which both groups maintained their pri- cultures of used tampons or pads.17 There have not been mary menstrual management strategy (ie, tampons). any published case reports of associ- The menstrual cup intervention began in menstrual ated with menstrual cup use. Cups have also been evaluated cycle 2 (study cycle 1), and continued for 2 more cycles with generally encouraging results as tools for the collection (study cycles 2 and 3). At the end of each study cycle, of shed menstrual tissue for analysis20,23; control of and vol- participants completed an end-of-cycle survey, in which ume measurement in menorrhagia19,20,24; and management convenience, insertion, wear, removal, comfort, leakage, of urine leakage in 3 subjects with vesicovaginal fistula.18,19 and overall satisfaction were rated on a 7-point Likert A randomized controlled trial comparing tampons with scale, with 1 being “terrible” and 7 being “fantastic.” At menstrual cups has never been done. The primary objec- the end of the 4 cycles, participants indicated their over- tive of this study was to determine if a menstrual cup is an all satisfaction with their assigned menstrual strategy in acceptable alternative to tampons in women aged 19 to an online final survey. 40 years, as measured by the participants’ overall satisfac- During each study cycle, participants kept online daily tion after 3 months of use, and whether the women would diaries detailing the number of menstrual products used continue using the product or recommend it to others. The and tracked episodes of subjective vaginal irritation as secondary objectives were to track subjective vaginal irri- well as physician diagnoses of UTI or vaginitis.25-32 Use tation, physician-diagnosed UTI and vaginitis, and esti- of additional products, such as pads, was at the discre- mates of cost and waste. tion of the participants and was recorded in the diaries. Diaries and surveys were based on those described in a previous study4; they have not been validated, owing Mt e hoDS to the novelty of the research, but were deemed the best option with which to prospectively collect data. Participants Participants were contacted by telephone by an inves- Women from Vancouver, Victoria, and Prince George, tigator 1 month after enrolment, and reminded monthly BC, were enrolled in this prospective randomized study via e-mail to complete the online diaries. A designated e210 Canadian Family Physician • Le Médecin de famille canadien | Vol 57: JUNE • JUIN 2011 FLOW (finding lasting options for women) | Research pager was carried by an investigator who was available Table 1. Cost calculations for menstrual products, by at all times in case of urgent questions. brand: Prices gathered on September 18, 2009, from This trial was approved by the Clinical Research Ethics London Drugs in West Vancouver, BC.* Board at the University of British Columbia in Vancouver Average (identifier number H06-70478) and was registered with units per Cost per Average unit cost of Product package, N package, $ unit cost, $ product, $ ClinicalTrials.gov (identifier number C06-0478). DivaCup 1 39.99 39.99 39.99 Statistical analysis Tampons 0.24 Sample size calculations were performed for the pri- • Tampax 20 4.69 0.23 mary outcome of overall satisfaction. Sixty-seven par- 40 8.29 0.21 ticipants in each group were required in order to have • o.b. 18 4.69 0.26 80% power to detect a difference in effect size of 0.50 40 7.99 0.20 using a 2-sided Mann-Whitney test. To account for a 10% loss to follow-up, we attempted to recruit 74 par- • 18 4.99 0.28 ticipants into each arm of the study. 36 8.99 0.25 Data were analyzed as intention-to-treat. † Categorical and numerical variables were compared Pantiliners 0.10 between groups using χ2 and Mann-Whitney tests, • 40 4.99 0.124 respectively. Satisfaction scores were reported as 72 7.99 0.11 means and standard deviations for final survey and end-of-cycle satisfaction outcomes, and comparisons • Kotex 45 4.29 0.10 96 7.99 0.08 between groups were calculated using Mann-Whitney tests. The proportion of participants in the menstrual • Carefree 46 4.49 0.10 cup group who would continue to use menstrual Pads† 0.23 cups or would recommend use to someone else was reported. Urovaginal irritation variables were com- • Always 18 4.49 0.25 pared between groups. 36 8.99 0.25 To calculate product waste, we averaged the num- • Stayfree 14 4.49 0.32 ber of tampons, pads, and pantiliners used per subject 48 7.99 0.17 in the run-in cycle. To estimate the monetary cost of menstrual management strategies, the average waste • Kotex 24 4.99 0.21 per cycle was multiplied by an averaged product cost Maxi 44 7.99 0.18 (Table 1). All analyses were performed using SAS (Statistical *Previous cost estimates done by FLOW investigators over the past 2 Analysis System, version 9.1). Significance was set at years were as follows: $0.24 per tampon and $0.09 per pantiliner in a Victoria survey; $0.37 per tampon and $0.24 per pad in a Vancouver P < .05. survey; and $38.99 per DivaCup at well.ca, $37.67 per DivaCup at lunapad.com, and $39.99 per DivaCup at londondrugs.com in an online survey of DivaCup prices. Our current estimate is in the same RESTS UL range as previous estimates; given that our methodology is more clearly laid out, we use our current estimate in our official cost calculations. †The prospectively gathered diary data from the run-in month, upon A total of 110 subjects were enrolled in the study ( Figure which the tampon and pad number estimates are based, do not 1), with 47 subjects in each group completing the final differentiate between pads and pantiliners, yet there is a substantial survey (13 were lost to follow-up, 3 discontinued the difference in cost between them. We have therefore gone through intervention); 5 were subsequently excluded from the the presurvey data regarding subjects’ retrospective estimates of the analysis after data revealed that they had taken antibi- tampons, pads, or pantiliners used per day to get an estimate of the average proportion of pads to pantiliners used in this popula- otics within 2 weeks of the start date of the study. At tion. The results were as follows: ratio of pads to pantiliners of 77 baseline, the tampon group was older and more likely to to 90; cost per pad or pantiliner, in dollars: ([0.77][0.23] + [0.90] have given birth (Table 2). More than half of the women [0.10])/1.67 = (0.177 + 0.09) /1.67 = 0.16. had a history of urovaginal symptoms (60 of 89). group than for the tampon group (5.4 [1.5] vs 5.0 [1.0], Final survey results P = .04; Figure 2). The menstrual cup group appeared Although the targeted sample size was not achieved, a to be more satisfied with respect to convenience (5.7 statistically significant difference in overall satisfaction [1.3] vs 5.2 [1.1], P = .02) and leakage (5.4 [1.4] vs was still found: the mean (standard deviation) 4.8[1.5], P = .04), but might have been less satisfied with satisfaction score was higher for the menstrual cup removal (5.0 [1.4] vs 5.5 [1.1], P = .06). Most women in

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Figure 1. Selection process for study participants

Women were assessed via e-mail; those who met inclusion criteria were invited to the information sessions and enrolled

Enrolment, N = 110

Randomization

Tampon group, n = 54 DivaCup group, n = 56

(Received allocated intervention, n = 54) Allocation (Received allocated intervention, n = 56)

Lost to follow-up, n = 5 Lost to follow-up, n = 8

-never logged in, n = 2 -never logged in, n = 2 -logged in once, n = 2 Follow-up - lled out 1 month, n = 3 - lled out 1 month, n = 1 - lled out 2 months, n = 1 - lled out almost everything, n = 2 Discontinued intervention, n = 2

-misunderstood inclusion criteria, n = 1 Discontinued intervention, n = 1

-became pregnant, n = 1 -too uncomfortable, n = 1

Completed nal survey, n = 47 Completed nal survey, n = 47 No source Excluded from analysis , n = 3 Excluded from analysis, n = 2 -data revealed women had used antibiotics in the 2 weeks -data revealed women had used antibiotics in the 2 weeks before study start date before study start date

Analyzed, n = 44 Analyzed, n = 45

Table 2. Participant demographics: N = 89.

Tampon Group Menstrual Cup Group Characteristic (N = 44) (N = 45) P Value* Mean (SD) age,† y 28.9 (5.5) 26.6 (4.6) .05

Race,† n (%) .58 • White 37 (90.2) 38 (86.4) • Other 4 (9.8) 6 (13.6)

Mean (SD) BMI,‡ kg/m2 23.9 (3.5) 24.0 (6.3) .12 ≥ 1 child, n (%) 8 (18.2) 2 (4.4) .04 Mean (SD) age of ,‡ y 13.0 (1.3) 13.0 (1.3) .80 Regular flow, n (%) 34 (82.9) 41 (95.3) .14

Flow,‡ n (%) .06 • Light 4 (9.8) 11 (25.6) • Medium 35 (85.3) 27 (62.8) • Heavy 2 (4.9) 5 (11.6)

Sexually active, n (%) 40 (97.6) 41 (93.2) .34 BMI—body mass index, SD—standard deviation. *Significance was set at P < .05. †Data missing for 4 participants. ‡Data missing for 5 participants.

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Figure 2. Final survey results: Median scores on a 7-point Likert scale with error bars representing interquartile ranges; N=89.

7

Tampons DivaCup n p

6

5 MEAN SCORE

4

3 Leakage Comfort Insertion Wear Removal Convenience Overall e t n r l e l

MEASURE OF SATISFACTION

*P < .05

the menstrual cup group said they would continue to cup group, the number of women reporting vaginal dis- use the cup (91%) and that they would recommend the comfort on at least 1 day per cycle decreased from 42% menstrual cup to others (91%). in study cycle 1 to 16% in study cycle 3.

End-of-cycle surveys Cost and waste End-of-cycle survey results are shown in Figure 3. Figure The median (first and third quartiles) number of tam- 3A shows that the tampon group had a small decline in pons used per subject in the run-in cycle was 10 (5 and overall satisfaction over time, whereas the menstrual cup 16) and the median (first and third quartiles) number group had a noticeable drop in the first cycle of cup use of pads or pantiliners used per subject was 3 (0 and 7). but then an increase to study end. Figures 3B and 3C Based on an average cost of 24 cents per tampon and show changes over time in each satisfaction variable. 16 cents per pad or pantiliner, this represents a cost of $2.88/cycle and $37.44/year (Table 1). This is similar Urovaginal symptoms to the retail cost of 1 DivaCup. There was a negligible The prevalence of physician-diagnosed urovaginal number of pads or pantiliners used during the study symptoms was low and did not differ between groups. cycles in the menstrual cup group; cost was not affected. Subjective vaginal discomfort was reported on at least 1 day during the run-in cycle by 9 (20%) and 12 (27%) women in the tampon and menstrual cup groups, DISU C SSION respectively (P = .49). Over the course of the 3 study cycles, 12 (27%) women in the tampon group and 23 In this population of women who normally used tampons, (51%) women in the menstrual cup group experienced we have shown that women who used a menstrual cup for discomfort on at least 1 day (P = .02). In the menstrual 3 cycles were at least as satisfied with the new menstrual

Vol 57: JUNE • JUIN 2011 | Canadian Family Physician • Le Médecin de famille canadien e213 Research | FLOW (finding lasting options for women) management strategy as women who continued with tam- Learning curve pon use. Cup users also found that their menstrual man- Consistent with previous studies,11,15 we found a trend agement was more convenient, and they appeared to be toward increased satisfaction with duration of men- more satisfied with regard to leakage. Most (91%) would strual cup use. Comments from the women included continue to use the cup and recommend it to others. the following: “My comfort level with the DivaCup increased a lot over the 3 months. It just took a bit of practice to easily insert and remove it!” and “I just Figure 3. End-of-cycle results, by recently trimmed the tip of the cup and that helped month, as measured by mean scores with comfort as well.” The study’s e-mail account and pager line received on a 7-point Likert scale: A) Overall numerous requests for advice during the first 2 cycles satisfaction, by study cycle; N=89. of cup use; this support, as well as the shorter study B) Tampon satisfaction data, by study period, might in part account for the lower dropout cycle; N=44. C) Menstrual cup satisfac- rate and higher acceptance rate than those of the tion data, by study cycle; N=45. Mooncup study,21 whose participants collected data for 6 months and had e-mail but not pager access to the investigators.

V aginitis, vaginal irritation, and UTI A) Tampon DivaCup Our study was not powered to find a statistically sig- 6.0 nificant difference in rates of physician-diagnosed UTI 5.6 or vaginitis, but overall rates were low in both groups. 5.2 More women in the menstrual cup group reported sub- 4.8 jective vaginal irritation. This decreased throughout the

MEAN SCORES FOR 4.4

OVERALL SATISFACTION study. Additional studies with larger sample sizes and 4.0 longer follow-up are required to compare comfort and Run-in Month 1 Month 2 Month 3

STUDY CYCLE clinical urovaginal infection rates between tampon and menstrual cup users.

Cost and waste B) Wear Removal Convenience* The DivaCup is guaranteed for 1 year under its licen- Leakage* Insertion Comfort sure with Health Canada, but it is expected to last for 6.0 several years. Taking into account this 1-year mini- 5.6 mum, the costs between the 2 strategies are com- 5.2 parable. If the cup were to be used for more than a 4.8 year, it would begin to represent a substantial cost 4.4 savings. Perhaps more important, during the run- MEAN SCORES FOR TAMPONS 4.0 Run-in Month 1 Month 2 Month 3 in month the women used 13 menstrual products

STUDY CYCLE per cycle, or 169 disposable menstrual products per year. To generate a rough estimate, if we were to assume that the 4 563 600 Canadian women between the ages of 20 and 39 years33 all menstruate regu- Wear Removal Convenience* C) Leakage* Insertion Comfort larly (assuming 13 cycles/woman each year) and 6.0 use products at this rate, then 771 248 400 dispos- 5.6 able menstrual products are being used every year 5.2 in Canada. Using menstrual cups would effectively 4.8 reduce this waste. MENSTRUAL CUPS MEAN SCORES FOR 4.4 4.0 Limitations Run-in Month 1 Month 2 Month 3 In addition to the limitations of a small study size STUDY CYCLE and short duration, as described above, we attempted to sample a cross-section of the population through multisite recruiting, but still had a mostly nulliparous *P < .05 and overwhelmingly white population. This limits the generalizability of the study results. e214 Canadian Family Physician • Le Médecin de famille canadien | Vol 57: JUNE • JUIN 2011 FLOW (finding lasting options for women) | Research

Conclusion 7. Chow AW, Bartlett KH. Sequential assessment of vaginal microflora in Studies with more subjects, longer follow-up, and more healthy women randomly assigned to tampon or napkin use. Rev Infect Dis 1989;11(Suppl 1):S68-73. diverse populations in terms of parity, ethnicity, and 8. Hochwalt AE, Jones MA, Sarbaugh FC, Lucas JD. Clinical safety in use of a culture should be undertaken. In particular, the utility layered-fiber tampon. Obstet Gynecol 2001;97(4 Suppl 1):S19-20. 9. Omar HA, Aggarwal S, Perkins KC. Tampon use in young women. J Pediatr of menstrual cups in underresourced environments Adolesc Gynecol 1998;11(3):143-6. with limited access to clean water and in women with 10. Hansen JG, Schmidt H. Vaginal discharge and Gardnerella vaginalis. 34-37 Predisposing factors. Scand J Prim Health Care 1985;3(3):141-3. vesicovaginal fistula needs to be assessed. 11. Hanna BA, Tierno PM Jr. Toxic shock syndrome toxin. JAMA The menstrual cup is a satisfactory alternative to 1985;254(15):2062. tampons in women who have previously used tampons 12. Tierno PM Jr, Hanna BA, Davies MB. Growth of toxic-shock-syndrome strain of after enzymic degradation of ‘Rely’ tampon compo- as their primary method of menstrual management. nent. Lancet 1983;1(8325):615-8. Physician-diagnosed urinary tract infections and vagi- 13. Veeh RH, Shirtliff ME, Petik JR, Flood JA, Davis CC, Seymour JL, et al. Detection of Staphylococcus aureus biofilm on tampons and menses compo- nitis comparisons between groups were inconclusive nents. J Infect Dis 2003;188(4):519-30. Epub 2003 Jul 25. owing to limited sample size. Menstrual cups have the 14. Wagner G, Bohr L, Wagner P, Petersen LN. Tampon-induced changes in vag- inal tensions. Am J Obstet Gynecol 1984;148(2):147-50. potential to be a sustainable solution to menstrual man- 15. Mahoney JR Jr. The role of oxygen in toxic shock syndrome. Med Hypotheses agement with moderate cost savings and much-reduced 1988;27(3):215-6. 16. Liswood R. Internal menstrual protection: use of a safe and sanitary men- environmental effects compared with tampons. strual cup. Obstet Gynecol 1959;13(5):539-43. Dr Howard is an emergency room physician practising in the Northwest 17. Karnaky KJ. Internal menstrual protection with the rubber menstrual cup. Territories and Ontario and a board member of the Canadian Association Obstet Gynecol 1962;19:688-91. of Physicians for the Environment. Ms Rose is a doctoral candidate at the 18. Pena EF. Menstrual protection. Advantages of the menstrual cup. Obstet University of British Columbia (UBC) in Vancouver and a statistician in the Gynecol 1962;19:684-7. Department of Medicine at UBC. Dr Trouton is Director of the Vancouver 19. Parker J, Bushell RW, Behrman SJ. Hygienic control of menorrhagia: use of Island Women’s Health Clinic in View Royan, BC, Clinical Associate Professor rubber menstrual cup. Int J Fertil 1964;9:619-21. in the Department of Medicine at UBC, and cofounder of the Canadian 20. Cheng M, Kung R, Hannah M, Wilansky D, Shime J. Menses cup evaluation Association of Physicians for the Environment. Dr Stamm is a family physi- study. Fertil Steril 1995;64(3):661-3. cian practising in Vancouver. Dr Marentette is a family physician practising in 21. Stewart K, Greer R, Powell M. Women’s experience of using the Mooncup. J Powell River, BC. Dr Kirkpatrick is an emergency room physician practising in Obstet Gynaecol 2010;30(3):285-7. Nanaimo, BC. Drs Karalic and Fernandez are family physicians practising in 22. Tierno PM, Hanna BA. Propensity of tampons and barrier contraceptives to Vancouver. Dr Paget is a family physician practising in Prince George, BC. amplify Staphylococcus aureus toxic shock syndrome toxin-I. Infect Dis Obstet Acknowledgment Gynecol 1994;2(3):140-5. Ryan Fugger provided website design and technical support during this 23. Koks CA, Dunselman GA, de Goeij AF, Arends JW, Evers JL. Evaluation of study. This study was supported by funding from the Research and Education a menstrual cup to collect shed for in vitro studies. Fertil Steril Foundation of the College of Family Physicians of Canada and the British 1997;68(3):560-4. Columbia College of Family Physicians; a grant from the Department of 24. Warrilow G, Kirkham C, Ismail KMK, Wyatt K, Dimmock P, O’Brien S. Family Practice at the University of British Columbia; and the Lloyd Jones Quantification of menstrual blood loss. The Obstetrician & Gynaecologist Collins Award from the Department of Family Practice at the University of 2004;6(2):88-92. Available from: http://onlinelibrary.wiley.com/ British Columbia. doi/10.1576/toag.6.2.88.26983/pdf. Accessed 2011 May 4. 25. Bent S, Saint S. The optimal use of diagnostic testing in women with acute Contributors uncomplicated cystitis. Dis Mon 2003;49(2):83-98. Dr Howard contributed to the study conception and design, literature review, 26. Bent S, Nallamothu BK, Simel DL, Fihn SD, Saint S. Does this woman have submission for ethics approval, building of the team and coordination of col- an acute uncomplicated urinary tract infection? JAMA 2002;287(20):2701-10. laborators, data collection and interpretation, writing of the first draft, and man- 27. Foxman B, Barlow R, D’arcy H, Gillespie B, Sobel JD. Urinary tract infection: uscript revisions. Ms Rose contributed to the study design, data analysis and self-reported incidence and associated costs. Ann Epidemiol 2000;10(8):509-15. interpretation, writing of the first draft, and manuscript revisions. Dr Trouton was the principal investigator on this study and contributed to the study design, 28. Hooton TM, Scholes D, Hughes JP, Winter C, Roberts PL, Stapleton AE, et al. submission for ethics approval, submissions for funding, interpretation of data, A prospective study of risk factors for symptomatic urinary tract infection in and manuscript revisions. Dr Stamm contributed to data collection, interpreta- young women. N Engl J Med 1996;335(7):468-74. tion of results, and manuscript revisions. Drs Marentette, Kirkpatrick, Karalic, 29. Schaaf VM, Perez-Stable EJ, Borchardt K. The limited value of symptoms and Fernandez, and Paget all contributed to the study design, collection of data, signs in the diagnosis of vaginal infections. Arch Intern Med 1990;150(9):1929- and manuscript revisions. 33. 30. Anderson MR, Klink K, Cohrssen A. Evaluation of vaginal complaints. JAMA Competing interests 2004;291(11):1368-79. None declared 31. Foxman B, Marsh JV, Gillespie B, Sobel JD. Frequency and response to vaginal Correspondence symptoms among white and African American women: results of a random Dr Courtney Howard and Dr Konia Trouton, Vancouver Island Women’s digit dialing survey. J Womens Health 1998;7(9):1167-74. Clinic, 104-284 Helmcken Rd, View Royal, BC V9B 1T2; telephone 250 480- 32. Allen-Davis JT, Beck A, Parker R, Ellis JL, Polley D. Assessment of vulvovagi- 7338; e-mail [email protected] nal complaints: accuracy of telephone triage and in-office diagnosis. Obstet Gynecol 2002;99(1):18-22. References 33. Statistics Canada. Population by sex and age group. Table No. 051-0001. 1. Wikipedia [encyclopedia on the Internet]. Menstrual cup. San Francisco, CA: Ottawa, ON: Statistics Canada; 2010. Available from: Wikimedia Foundation Inc; 2011. Available from: http://en.wikipedia.org/ http://www40.statcan. wiki/Menstrual_cup. Accessed 2011 May 3. gc.ca/l01/cst01/demo10a-eng.htm?sdi=population%20sex%20age%20 2. Stewart K, Powell M, Greer R. An alternative to conventional sanitary protec- group. Accessed 2011 May 4. tion: would women use a menstrual cup? J Obstet Gynaecol 2009;29(1):49-52. 34. Tiwari H, Oza UN, Tiwari R. Knowledge, attitudes and beliefs about men- 3. Dickinson RL. Tampons as menstrual guards. Trained Nurse Hosp Rev arche of adolescent girls in Anand district, Gujarat. East Mediterr Health J 1946;116:107-9. 2006;12(3):428-33. 4. Shehin SE, Jones MB, Hochwalt AE, Sarbaugh FC, Nunn S. Clinical safety-in- 35. Hennink M, Rana I, Iqbal R. Knowledge of personal and sexual development use study of a new tampon design. Infect Dis Obstet Gynecol 2003;11(2):89-99. amongst young people in Pakistan. Cult Health Sex 2005;7(4):319-32. 5. Onderdonk AB, Delaney ML, Zamarchi GR, Hirsch ML, Munoz A, Kass EH. 36. Bharadwaj S, Patkar A. Menstrual hygiene and management in developing Normal vaginal microflora during use of various forms of catamenial protec- countries: taking stock. 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